TIDMHIK
Hikma Pharmaceuticals Plc
10 December 2019
London and Salt Lake City, UT, December 10, 2019 - Civica Rx
(Civica, Inc.) and Hikma Pharmaceuticals PLC (Hikma, Group) (LSE:
HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated Ba1/stable Moody's and
BB+/positive S&P), the multinational generic pharmaceutical
company, today announced imminent shipments of Heparin Sodium
Injection, USP, and seven other essential injectable medicines,
with additional products to follow in the near term in the US
through its affiliate, Hikma Pharmaceuticals USA Inc(1) .
Today's announcement comes as industry experts work to avoid an
extended shortage of Heparin, the preferred anticoagulant for many
hospitalized patients. Heparin is commonly prescribed for patients
with significant blood clots in their lungs or clogged arteries,
and patients receiving dialysis, or undergoing major orthopedic and
cardiac surgery. It is prescribed to more than 10 million Americans
every year.
Shortages of Heparin, which is derived from porcine intestinal
mucosa, may be possible due to an outbreak of African Swine Fever
that has killed an unprecedented number of the world's pigs. The
outbreak has predominantly impacted China, home to half of the
world's swine population. Hikma sources its Heparin raw materials
from the US, and has not been impacted.
In addition to Heparin, the Civica Rx-Hikma partnership will be
shipping additional medications, including essential shortage
medications^, before the end of the year, including:
-- Naloxone Hydrochloride Injection, USP - Naloxone is an opioid
antagonist medication used to block or reverse the effects of
opioid drugs, particularly drug overdoses. It works by blocking the
effects of the opioid in the brain and is often used in hospitals
and EMS services.
-- Dexamethasone Sodium Phosphate Injection, USP(^) -
Dexamethasone is a steroid used to treat various conditions such as
severe allergic reactions, arthritis, blood diseases, breathing
problems, certain cancers, eye diseases, intestinal disorders, and
skin diseases. It decreases the body's natural defensive response
and reduces symptoms such as swelling and other physical
reactions.
-- Glycopyrrolate Injection, USP - Glycopyrrolate is used in
surgeries to reduce airway secretions or to prevent heart rhythm
problems during anesthesia, intubation, or surgery.
-- Prochlorperazine Edisylate Injection, USP - Prochlorperazine
is used to control severe nausea and vomiting caused by
chemotherapy, radiation therapy, and in the pre- and post-operative
setting.
-- Ondansetron Injection, USP(^) - Ondansetron is used to
prevent nausea and vomiting that may be caused by surgery or cancer
chemotherapy.
-- Morphine Sulfate Injection, USP(^) - Morphine is a narcotic
analgesic medication used to relieve moderate to severe pain. It
may be also be used before or during surgery with an
anesthetic.
-- Metoprolol Tartrate Injection, USP(^) - Metoprolol is a beta-blocker used to treat angina and hypertension. It is also used to lower the risk of death or need for hospitalization for heart failure.
"We are thrilled to be delivering on our partnership's promise
to ensure vital medications are consistently available for
hospitals and patients who need them," said Martin VanTrieste,
President and CEO of Civica Rx. "These shipments reinforce our
confidence in Hikma's expertise and manufacturing capabilities and
it's especially gratifying that the initial deliverable of our
partnership will help ensure an increased supply of heparin at a
time when there is an ongoing threat to supply."
"As a leading provider of generic injectable medicines, Hikma is
committed to working across the US healthcare system on long-term,
sustainable solutions to help ensure a consistent supply of needed
medicines to patients," said Riad Mishlawi, President, Hikma
Injectables. "Our partnership with Civica is an excellent example
of combining Hikma's strong manufacturing capabilities and strong
quality and supply record with Civica's extensive network of more
than 1,100 US hospitals. We are pleased that patients and
healthcare providers across the country will now begin benefiting
from Civica's forward-thinking approach."
(1) Hikma Pharmaceuticals USA Inc. was formerly known as
West-Ward Pharmaceuticals Corp.
(^) Denotes essential shortage medication
Civica Rx & Hikma's Partnership
Under the partnership with Civica Rx, announced last July, Hikma
will produce 14 essential sterile injectable medications for
Civica, using Hikma's Abbreviated New Drug Applications (ANDAs) and
Civica's National Drug Code (NDC) and label. These medicines are
used daily by hospitals in emergency care, surgery, pain management
and in treating hypertension.
Importantly, Civica Rx's ability to coordinate directly with
manufacturers like Hikma enables it to ensure that the APIs (active
pharmaceutical ingredients) in Civica Rx drugs are purchased from
reputable, high-quality suppliers. As a result, Civica Rx and its
partners manufacture and deliver generic drugs that conform to
strict industry standards of quality, strength and purity.
Civica was founded in 2018 by leading US hospital systems
concerned about generic drug shortages and philanthropic
organizations passionate about improving healthcare. To date, more
than 45 health systems are Civica members, representing more than
1,100 US hospitals and over 30 percent of all licensed US hospital
beds.
Hikma is the third largest US supplier by volume of generic
injectable medicines with a growing portfolio of more than 100
injectable products. Today, one in every six generic injectable
medicines used in US hospitals is a Hikma product. During the last
three years, Hikma has launched more than 20 medications into US
shortage situations and in 2016 the company received a Drug
Shortage Assistance Award from the US Food and Drug Administration
(FDA) for its role in preventing or alleviating drug shortages.
Earlier this fall, Civica delivered two essential antibiotics
through its partnership with Xellia Pharmaceuticals to member
hospitals which are being administered daily to patients
nationwide. The organization plans to announce shipments of
additional life-saving drugs in the near future.
-S -
Enquiries
Hikma Pharmaceuticals PLC
Susan Ringdal +44 (0)20 7399 2760/ +44 7776
EVP, Strategic Planning and Global 477050
Affairs uk-investors@hikma.com
Steven Weiss +1 732 720 2830/ +1 732 788 8279
Senior Director, Communications sweiss@hikma.com
and Public Affairs
Civica Rx
Debbi Ford +1 970 227 3991
Debbi.ford@civicarx.org
About Civica Rx
Civica Rx was established in 2018 by health systems
(CommonSpirit Health, HCA Healthcare, Intermountain Healthcare,
Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity
Health) and philanthropies (Gary and Mary West Foundation, Laura
and John Arnold Foundation, and Peterson Center on Healthcare) to
reduce chronic generic drug shortages and related high prices in
the United States. It exists in the public interest as a
non-profit, non-stock corporation committed to stabilizing the
supply of essential generic medications in a hospital setting.
Civica is committed to transparency and offers fair and
sustainable prices to its member hospitals. It will also ensure it
has dedicated manufacturing capacity for the medications that are
most desperately needed in hospitals across the country through
redundant manufacturing and a strategic safety stock of medications
to help prevent drug shortages in the future.
Civica aims to stabilize the supply of antibiotics, anesthetics,
cardiac medications, pain management medications, and other
essential sterile injectable medicines used in hospitals daily. It
is actively pursuing a three-pronged product supply strategy:
-- Working with multiple generic drug manufacturers that have
the US FDA approved manufacturing facilities and capacity to
produce Civica labeled generic drugs, allowing manufacturers to
re-enter the market or increase existing capacity.
-- Developing Abbreviated New Drug Applications (ANDAs) for
generic drugs and working with contract manufacturing organizations
to produce Civica medications.
-- Acquiring/building Civica manufacturing facilities using Civica's ANDAs
Find more information about Civica Rx at www.civicarx.org
About Hikma
Hikma helps put better health within reach every day for
millions of people in more than 50 countries around the world. For
more than 40 years, we've been creating high-quality medicines and
making them accessible to the people who need them. Headquartered
in the UK, we are a global company with a local presence across the
United States (US), the Middle East and North Africa (MENA) and
Europe, and we use our unique insight and expertise to transform
cutting-edge science into innovative solutions that transform
people's lives. We're committed to our customers, and the people
they care for, and by thinking creatively and acting practically,
we provide them with a broad range of branded and non-branded
generic medicines. Together, our 8,400 colleagues are helping to
shape a healthier world that enriches all our communities. We are a
leading licensing partner, and through our venture capital arm, are
helping bring innovative health technologies to people around the
world. For more information, please visit: www.hikma.com
See below for Important Safety Information regarding products
containing Boxed Warnings, which includes Prochlorperazine
Edisylate Injection, USP.
Important Safety Information for Prochlorperazine Edisylate
Injection, USP:
BOXED WARNING
Increased Mortality in Elderly Patients with Dementia-Related
Psychosis
Elderly patients with dementia-related psychosis treated with
antipsychotic drugs are at an increased risk of death. Analyses of
seventeen placebo-controlled trials (modal duration of 10 weeks),
largely in patients taking atypical antipsychotic drugs, revealed a
risk of death in drug-treated patients of between 1.6 to 1.7 times
the risk of death in placebo-treated patients. Over the course of a
typical 10-week controlled trial, the rate of death in drug-treated
patients was about 4.5%, compared to a rate of about 2.6% in the
placebo group. Although the causes of death were varied, most of
the deaths appeared to be either cardiovascular (e.g., heart
failure, sudden death) or infectious (e.g., pneumonia) in nature.
Observational studies suggest that, similar to atypical
antipsychotic drugs, treatment with conventional antipsychotic
drugs may increase mortality. The extent to which the findings of
increased mortality in observational studies may be attributed to
the antipsychotic drug as opposed to some characteristic(s) of the
patients is not clear. Prochlorperazine Edisylate Injection, USP is
not approved for the treatment of patients with dementia-related
psychosis.
CONTRAINDICATIONS
Do not use in patients with known hypersensitivity to
phenothiazines. Do not use in comatose states or in the presence of
large amounts of central nervous system depressants (alcohol,
barbiturates, narcotics, etc.). Do not use in pediatric surgery. Do
not use in pediatric patients under 2 years of age or under 20 lbs.
Do not use in children for conditionsfor which dosage has not been
established.
WARNINGS & PRECAUTIONS
The following warnings and precautions should be taken when
administering Prochlorperazine Edisylate Injection, USP:
-- Elderly patients with dementia-related psychosis treated with
antipsychotic drugs are at an increased risk of death.
Prochlorperazine Edisylate Injection, USP is not approved for the
treatment of patients with dementia-related psychosis.
-- The extrapyramidal symptoms which can occur secondary to
prochlorperazine may be confused with the central nervous system
signs of an undiagnosed primary disease responsible for the
vomiting, e.g., Reye's syndrome or other encephalopathy. The use of
prochlorperazine and other potential hepatotoxins should be avoided
in children and adolescents whose signs and symptoms suggest Reye's
syndrome.
-- Tardive dyskinesia, a syndrome consisting of potentially
irreversible, involuntary, dyskinetic movements may develop in
patients treated with antipsychotic drugs. The prevalence of the
syndrome appears to be highest among the elderly, especially
elderly women.
-- A potentially fatal symptom complex sometimes referred to as
Neuroleptic Malignant Syndrome (NMS) has been reported in
association with antipsychotic drugs.
-- Prochlorperazine may cause somnolence, postural hypotension,
motor and sensory instability, which may lead to falls and,
consequently, fractures or other injuries.
-- An encephalopathic syndrome (characterized by weakness,
lethargy, fever, tremulousness and confusion, extrapyramidal
symptoms, leukocytosis, elevated serum enzymes, BUN and FBS) has
occurred in a few patients treated with lithium plus an
antipsychotic. In some instances, the syndrome was followed by
irreversible brain damage.
-- Patients with bone marrow depression or who have previously
demonstrated a hypersensitivity reaction (e.g., blood dyscrasias,
jaundice) with a phenothiazine should not receive any
phenothiazine, including prochlorperazine, unless in the judgment
of the physician the potential benefits of treatment outweigh the
possible hazards.
-- Prochlorperazine may impair mental and/or physical abilities,
especially during the first few days of therapy.
-- Phenothiazines may intensify or prolong the action of central
nervous system depressants (e.g., alcohol, anesthetics,
narcotics).
-- Neonates exposed to antipsychotic drugs, during the third
trimester of pregnancy are at risk for extrapyramidal and/or
withdrawal symptoms following delivery. Prochlorperazine Edisylate
should be used during pregnancy only if the potential benefit
justifies the potential risk to the fetus. Safety for the use of
prochlorperazine during pregnancy has not been established.
-- There is evidence that phenothiazines are excreted in the
breast milk of nursing mothers. Caution should be exercised when
prochlorperazine is administered to a nursing woman.
-- In clinical trial and postmarketing experience, events of
leukopenia/neutropenia and agranulocytosis have been reported
temporally related to antipsychotic agents.
-- Prochlorperazine's antiemetic action may mask signs and
symptoms of overdosage of other drugs and may obscure the diagnosis
and treatment of other conditions such as intestinal obstruction,
brain tumor and Reye's syndrome. When prochlorperazine is used with
cancer chemotherapeutic drugs, vomiting as a sign of toxicity of
these agents may be obscured by the antiemetic effect of
prochlorperazine.
-- Antipsychotic drugs elevate prolactin levels; the elevation
persists during chronic administration.
-- As with all drugs which exert an anticholinergic effect,
and/or cause mydriasis, prochlorperazine should be used with
caution in patients with glaucoma.
-- Because phenothiazines may interfere with thermoregulatory
mechanisms, use with caution in persons who will be exposed to
extreme heat.
-- Phenothiazines can diminish the effect of oral anticoagulants.
-- Phenothiazines can produce alpha-adrenergic blockade.
-- Thiazide diuretics may accentuate the orthostatic hypotension
that may occur with phenothiazines.
-- Antihypertensive effects of guanethidine and related
compounds may be counteracted when phenothiazines are used
concomitantly. Concomitant administration of propranolol with
phenothiazines results in increased plasma levels of both
drugs.
-- Phenothiazines may lower the convulsive threshold; dosage
adjustments of anticonvulsants may be necessary.
-- The presence of phenothiazines may produce false-positive phenylketonuria (PKU) test results.
-- Children with acute illnesses (e.g., chickenpox, CNS
infections, measles, gastroenteritis) or dehydration seem to be
much more susceptible to neuromuscular reactions, particularly
dystonias, than are adults. In such patients, the drug should be
used only under close supervision.
-- Drugs which lower the seizure threshold, including
phenothiazine derivatives, should not be used with metrizamide.
-- Clinical studies of prochlorperazine did not include
sufficient numbers of subjects aged 65 and over to determine
whether elderly subjects respond differently from younger subjects.
Geriatric patients are more sensitive to the side effects of
antipsychotics, including prochlorperazine.
ADVERSE REACTIONS
NOTE: There have been occasional reports of sudden death in
patients receiving phenothiazines. In some cases, the cause
appeared to be cardiac arrest or asphyxia due to failure of the
cough reflex.
Drowsiness, dizziness, amenorrhea, blurred vision, skin
reactions and hypotension may occur. Neuroleptic Malignant Syndrome
(NMS) has been reported in association with antipsychotic drugs.
Cholestatic jaundice has occurred. Motor Restlessness may include
agitation or jitteriness and sometimes insomnia. Pseudoparkinsonism
symptoms may include mask-like facies, drooling, tremors,
pillrolling motion, cogwheel rigidity, and shuffling gait. Avoid
getting the injection solution on hands or clothing because of the
possibility of contact dermatitis.
Not all of the following adverse reactions have been observed
with every phenothiazine derivative but they have been reported
with one or more and should be borne in mind when drugs of this
class are administered: extrapyramidal symptoms (opisthotonos,
oculogyric crisis, hyperreflexia, dystonias, akathisia, dyskinesia,
parkinsonism); grand mal and petit mal convulsions; altered
cerebrospinal fluid proteins; cerebral edema; intensification and
prolongation of the action of central nervous system depressants
(opiates, analgesics, antihistamines, barbiturates, alcohol),
atropine, heat, organophosphorus insecticides; autonomic reactions
(dryness of mouth, nasal congestion, headache, nausea,
constipation, obstipation, adynamic ileus, ejaculatory
disorders/impotence, priapism, atonic colon, urinary retention,
miosis and mydriasis); reactivation of psychotic processes,
catatonic-like states; hypotension (sometimes fatal); cardiac
arrest; blood dyscrasias (pancytopenia, thrombocytopenic purpura,
leukopenia, agranulocytosis, eosinophilia, hemolytic anemia,
aplastic anemia); liver damage (jaundice, biliary stasis);
endocrine disturbances (hyperglycemia, hypoglycemia, glycosuria,
lactation, galactorrhea, gynecomastia, menstrual irregularities,
false-positive pregnancy tests); skin disorders (photosensitivity,
itching, erythema, urticaria, eczema up to exfoliative dermatitis);
other allergic reactions (asthma, laryngeal edema, angioneurotic
edema, anaphylactoid reactions); peripheral edema; reversed
epinephrine effect; hyperpyrexia; mild fever after large IM doses;
increased appetite; increased weight; a systemic lupus
erythematosus-like syndrome; pigmentary retinopathy; with prolonged
administration of substantial doses, skin pigmentation, epithelial
keratopathy, and lenticular and corneal deposits.
EKG changes-particularly nonspecific, usually reversible Q- and
T-wave distortions-have been observed in some patients receiving
phenothiazines. Although phenothiazines cause neither psychic nor
physical dependence, sudden discontinuation in long-term
psychiatric patients may cause temporary symptoms, e.g., nausea and
vomiting, dizziness, tremulousness.
For additional information, please refer to the Package Insert
at
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e3e0c6c5-6b92-40e0-a926-29c64846be93&audience=professional
for full prescribing information, available on www.hikma.com.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or
call 1-800-FDA-1088.
Manufactured by:
Hikma Pharmaceuticals USA Inc. (formerly West-Ward, A Hikma
Company)
Eatontown, NJ 07724 USA
Document identification number: WW20374
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
NRATMBTTMBMBBML
(END) Dow Jones Newswires
December 10, 2019 07:06 ET (12:06 GMT)
Grafico Azioni Hikma Pharmaceuticals (LSE:HIK)
Storico
Da Mar 2024 a Apr 2024
Grafico Azioni Hikma Pharmaceuticals (LSE:HIK)
Storico
Da Apr 2023 a Apr 2024